Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Wisconsin, Madison
About this trial
This study is exploring how psilocybin (a psychedelic drug) may improve mood and wellbeing. Many people report feeling better after taking psilocybin, but it is not clear why. The CoPEWell study will test whether these improvements come from the psychedelic experience itself (the "trip") or from direct effects on the brain. To study this, up to 120 participants will be enrolled to receive psilocybin either while awake or asleep and can expect to be on study for up to 4 months.
Eligibility criteria
Qualifiers
Age 18 to 45 years (inclusive) at screening, of any identified gender and racial/ethnic group
Physically healthy; does not meet criteria for an exclusionary medical condition
No exclusionary sleep condition
English-speaking (able to provide consent and complete questionnaires)
Disqualifiers
Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
Exclusionary medical conditions or sleep conditions
Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
Clinically significant electrocardiogram (ECG)
Trial design
Treatments tested in this trial
- Psilocybin
- Saline Placebo
- Clonidine
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Tiny Blue Dot Foundation
Collaborator
Source ClinicalTrials.gov